NIA Administrative Supplements for Translational Research Leading to New Interventions, Health Practices and Policies

Notice Number: NOT-AG-08-003

Key Dates
Release Date:  April 7, 2008
Application Receipt Date:  December 5, 2008
Earliest Anticipated Start Date:  February 1, 2009   However, the Award date of the supplement will be matched with the start date of the next funding period of the parent grant.

Issued by
National Institute on Aging (NIA), http://www.nia.nih.gov

Purpose

The National Institute on Aging announces the availability of funds in fiscal year 2009 (FY09) that are specifically designated for translational aging research leading to new interventions, health practices and policies. Applicants may apply for supplemental funding in connection with NIA-supported Research Project (R01), MERIT (R37), Program Projects (P01) and Cooperative Agreement (U01) awards to domestic institutions.  Potential applicants are strongly encouraged to communicate with their Program Official prior to submission of a request for this supplemental funding opportunity. Applicants may request up to two years of supplemental funding (i.e., $100,000 direct costs/year).  However, all applicants must request a minimum of 12 months of support. A full second year or increments of a second year of support may also be requested. For those applications requesting support beyond one full year, the continuation of funding of any increments of the second year will be dependent on demonstrated progress on milestones established by the PI and approved by program staff.  Thus, this supplemental funding program is intended to facilitate the course of research from the original research findings to a point where further support of an independent, translational project grant can be applied for under other mechanisms such as the R01 or P01. At the end of the supplemental funding period, awardees will be required to submit a brief (1-2 pages) summary of the findings, whether additional testing of the proposed intervention is warranted, any publications resulting from the supplemental translational project and future plans for subsequent development of the translational idea (e.g., submission of R01 or P01, planned collaborations with Industry or relevant organizations or government agencies). 

Requests for administrative supplements must include information demonstrating that the projects meet the following conditions: (1) the focus of the supplemental research being proposed is within the scope of the research being performed under the parent NIA-supported grant; (2) there are no funds in the parent award to specifically pay for the proposed effort; (3) the parent grant was originally awarded for the period of time that will be requested for the supplement (see section on Eligibility for further guidance); and (4) the Principal Investigator (PI) for the supplement must be the PI of the parent grant.  Potential applicants are strongly encouraged to communicate with their Program Official to determine eligibility for this funding opportunity, to discuss the planned application and to obtain approval of their proposed supplemental project prior to submission.

Awardees from Notice AG-07-006 are NOT eligible for the current funding opportunity unless the proposed supplemental study is to a different NIA-supported parent grant. 

Depending on the merit of the requests received and the availability of funds, the NIA may award up to $3.0 million per year in supplemental funding in connection with this funding opportunity announcement in FY09.  Approximately 20 supplement awards are anticipated.

Background

The mission of the NIA is to improve the health and well-being of older Americans, especially to extend the healthy, active years of life. Though investigators in basic and clinical aging research recognize the value of therapies targeted at aging changes, there has been very little progress made in incorporating advances from basic aging research into new interventions (“T1” translational research). The availability of novel interventions (both pharmacological and non-pharmacological approaches) targeted at aging changes could be applied for primary prevention, provide alternative therapeutic options for older adults or could be used as adjunctive therapy to improve efficacy of existing interventions. Similarly, the process of research translation from biomedical, behavioral and social science studies into improved health practices and policies (“T2” translational research) benefiting older adults has been limited. The NIA initiated an administrative supplement funding program for translational aging research in 2007 (see http://grants.nih.gov/grants/guide/notice-files/NOT-AG-07-006.html). The current funding opportunity reflects NIA’s continued commitment to encouraging researchers to move into and become active in translational aging research (T1 and T2) and building capacity for early translational research projects.

Research Objectives

The primary objective of this announcement for administrative supplements is to facilitate the broad range of studies needed for the translation of both basic aging research into new interventions targeting aging conditions (“T1” translational research) and for implementation of health practices and policies affecting the elderly (“T2”). Requests for supplemental funding for “T1” research may involve studies leading to the development of new drugs, therapeutic biological products, as well as to the development of non-pharmacological interventions (e.g. exercise) and devices targeted at preventing or improving aging related conditions or pathologies. Investigators with NIA-funded basic research parent projects must demonstrate within the request that the course of research extends the results from their parent grant using appropriate models and techniques for eventual clinical development. The application must propose a course of investigation that clearly progresses toward clinical testing of the proposed treatment, with milestones to be achieved during the period of supplemental funding.

Translational research projects proposed in humans must provide evidence of approval for inclusion of human subjects and necessary assurances for human subjects as part of their parent NIA-supported study. Please also refer to NIA policies for human intervention studies if human testing is proposed. If human testing of a new chemical entity is proposed, the applicant is required to have an existing Investigational New Drug (IND) application with the Food and Drug Administration (FDA) and have completed the preclinical studies to support the proposed human testing, per FDA guidance.

“T1” translational studies appropriate for this NIA supplemental funding opportunity include various types of studies needed to better define therapeutic targets and/or to test effects of proposed new interventions. Exploratory studies in both animals and in humans may be proposed. The type of translational studies to be supported under this funding opportunity will depend on the stage of development of the scientific field. Because this funding opportunity is for supplements to existing grants, the goals of each of the four programs within NIA are slightly different, and they are stated below. Applicants must communicate with the Program Official associated with their active grant to establish eligibility and other criteria.

Biology of Aging Program (BAP)
Supplements to grants administered by BAP should be directed towards gathering more substantive evidence of the translational potential of therapeutic interventions to retard or reverse age-related conditions such as sarcopenia, osteoporosis, impaired wound healing and/or immunodeficiencies, among others. These administrative supplements may be used to pursue in vivo or vitro studies designed to validate the potential of new targets that have been identified for possible use as therapeutics for various age-related pathologies. Supplements may be used to support a range of studies, including work in model organisms or animal models, to evaluate the translational potential of treatments for aging conditions. Examples of aging-specific potential translational projects of interest to BAP include, but are not limited to:

Neuroscience and Neuropsychology of Aging (NNA) Program
The Neuroscience and Neuropsychology of Aging Program will be providing administrative supplements for research aimed at the validation of novel therapeutic targets for the following conditions and diseases of aging:

Approaches aimed at manipulating the expression and/or function of a molecular target both in vitro and in vivo and demonstrating that these manipulations critically influence molecular, biochemical, electrophysiological, cognitive and other behavioral readouts relevant to the above conditions will be eligible for support.  Acceptable manipulations include but are not limited to the generation and use of: i) antisense DNA/RNA oligonucleotides, ii) gene silencing using interfering RNAs (dsRNA, siRNA); iii) transgenic animal models such as conditional knockouts, knock-ins or gain of function models.  The use of various model organisms such as C. Elegans, Drosophila Melanogaster, mice, rats, non-human primates and others, for the purpose of validating a new target is strongly encouraged.

The Neuroscience and Neuropsychology of aging program is also interested in proof-of-concept preclinical studies aimed at assessing the impact of pharmacological and non-pharmacological interventions such as diet and exercise on the above-listed conditions and diseases of aging and/or the impact of these interventions on molecular, biochemical, electrophysiological, cognitive and behavioral outcomes associated with these disorders.

Geriatrics and Clinical Gerontology (GCG) Program
The Geriatrics and Clinical Gerontology Program is interested in the full range of translational research from bench to bedside (“T1”), as well as the application of findings from clinical research to the development of new healthcare strategies and policies for older adults (“T2”). Requests for supplemental funding to GCG-supported grants may involve studies leading to the development of new drugs or therapeutic biological products, as well as to the development of non-pharmacological interventions (e.g., exercise) and devices targeted at aging conditions or processes. Topics of interest include, but are not limited to translational studies leading to novel interventions for prevention or treatment of aging conditions, geriatric syndromes, and previously unappreciated pathologic conditions in old age.  Examples of potential types of translational projects include, but not limited to:

Topics of interest to GCG related to translational studies leading to improved health care and polices include but are not limited to those listed below by the Behavioral and Social Research Program.

Behavioral and Social Research (BSR) Program
BSR is interested in “T2” studies which will lead to translation of research results to public policy or private-sector decisions. Requests for supplemental funding for “T2” translational research of interest to BSR will be specifically designated for behavioral and social science studies (or other studies that would benefit from social, behavioral and economic approaches) with research results relevant for 1) translation into state/federal/international public policy, 2) adoption by agencies or firms (e.g., insurance companies, employers, nursing homes), 3) translation into public health practice, 4) development into new technologies, and 5) development into behavior change/behavior maintenance programs. These supplements must have an aging or lifespan focus. Where appropriate, administrative supplement funds may be requested to collect additional data and to work with relevant organizations urging adoption of new or changed policies or programs. Appropriate topics for these supplements include, but are not limited to the following.

Eligibility

Potential applicants are strongly encouraged to communicate with their Program Official to determine eligibility for this funding opportunity, to discuss the planned application and to obtain approval of their proposed supplemental project prior to submission.  Only one supplement may be requested for any individual award.

This program will support administrative supplements to NIA-supported Research Project (R01), MERIT (R37), and Cooperative Agreement (U01) awards to domestic institutions. The parent NIA-supported grant must be active during the entire funding period of the requested supplement. All applications must request a minimum of one full year of support (beginning with the start date of the next funding period of the parent grant).  The parent NIA grant must be actively funded at least through November 2009 in order to be eligible. The parent NIA grant must be active through November 2010 for any applications requesting up to two years of support (i.e., any increments of time requested during second year of support must fall within the project end date of the parent grant). 

Unsuccessful applicants to Notice AG-07-006 are allowed to revise and resubmit supplemental projects in response to the current funding opportunity.  It should be noted in a cover letter that the application is a resubmission. Awardees from Notice AG-07-006 are not eligible for the current funding opportunity unless the proposed supplemental study is to a different NIA-supported parent grant. 

Awards to foreign institutions are not eligible for supplementation under this program.  Applications for these supplements will not be accepted until after a Notice of Grant Award has been issued for the parent grant application. These supplements are not intended to provide bridge funding and grants on no-cost extensions (beginning on or before December 1, 2009) are considered ineligible for this supplemental funding opportunity.

Translational research projects proposed in either vertebrate animals or in humans that do not contain approval for use of vertebrate animals or inclusion of human subjects and necessary assurances as part of their parent NIA-supported study will be considered ineligible for this funding opportunity.

How to Apply

This is a one-time announcement. Applications must be received on or before December 5, 2008. Do not send applications to the Center for Scientific Review. Applicants should submit one electronic copy as an e-mail attachment in PDF format and one hard copy (with original signatures of the PI and institutional official) of the application to:

Chhanda Dutta, PhD Chief,
Clinical Gerontology Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C-307
Bethesda, MD 20892 (ZIP 20814 for Fed Ex)
Telephone: (301) 435-3048
FAX (301) 402-1784
Email: duttac@nia.nih.gov

Content and Form of Application Submission

Applications for an administrative supplement under this program should use the PHS 398 form (rev. 11/2007); available at  http://grants1.nih.gov/grants/funding/phs398/phs398.html and must include the following:

1. Cover letter requesting the supplement, identifying this notice, the number and title of the parent grant, and providing full principal investigator (PI) contact information.

2. Face page.

The title of the project (Box 1) should be the title of the parent award.

This Notice (number and title) should be cited in Box 2, and the “yes” box should be checked.

The Principal Investigator (PI) must be the same as the PI on the parent award. Subproject PIs on P01 and U01 awards are not eligible to apply for these supplements.

The remaining items on the face page should be filled out according to the PHS 398 application instructions.

3. Form page 2 (Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells) from PHS 398. The project description is that of the administrative supplement, not the parent grant.

4. Biosketch(es) for any new key personnel or consultants not named in the parent grant. Letters of commitment from these new participants should be included in section 16 (Consultants) of the Research Plan.

5. Resources page and Other Support page for any new key personnel not named in the parent grant.

6. Budgets may not exceed $100,000 in direct costs (exclusive of Facilities and Administrative (F&A) costs requested by consortium participants) per year. All requests require an itemized budget and must be countersigned by the grantee institution’s business office on the face page. See “Budget Information” section below.

7. A one-page description of the parent award, including a brief update on progress made thus far.

8. Research Plan for the supplement, sections 2-5 not to exceed five pages. Font size restrictions apply as designated within the PHS398 (rev. 11/2007) instructions.

The application should contain sufficient detail (similar to a standard research application) to allow assessment of the scientific merit of the proposed research plans and the appropriateness of the request for supplemental funding. This section should include a description of the supplement's specific aims (2), background and significance (3), preliminary studies (4), and research design and methods (5). It must also describe how the specific aims of the parent project will be enhanced by the supplement, and should make a strong scientific case that the proposed supplemental research will make a substantial contribution to the translation of the system under study in the parent grant towards clinical or public policy application. If collaborators are not at the same institution, describe how they will work together on the supplement project.

Bibliography and References Cited (7) should be completed as described in the PHS 398 instructions. List any publications (including accepted manuscripts) resulting from the parent grant in this section (7b).

Protection of Human Subjects (section 8 of the Research Plan): If there is a change, relative to the parent award, in any matter related to human subjects research, the application should include a complete Protection of Human Subjects section (8) as required in the PHS 398 instructions. This section will not be counted toward the five-page limit of the research plan. We urge all applicants to begin the process of obtaining IRB approval of any changes to the human subject protocols covering the parent award as soon as possible, if the supplementary project requires it. If there is no change, relative to the parent award, in any matter related to human subjects research, this should be stated. If human subjects are involved, requests for supplements under this program must comply with NIH policies for inclusion of women, minorities and children in research involving human subjects.

Sections 9 (Inclusion of Women and Minorities), 10 (Targeted/Planned Enrollment Table), 11 (Inclusion of Children), 12 (Vertebrate Animals), 13 (Select Agent Research), 15 (Consortium/Contractual Arrangements), and 16 (Consultants) should be completed as described in the PHS 398 instructions.
Sections 14 (Multiple PD/PI Leadership Plan) and 17 (Resource Sharing Plans) are not required.

9. A completed Checklist.

10. Appendices will not be accepted.

Review Criteria

Requests will be evaluated by NIH program staff with expertise relevant to the proposed translational research project. The applicant will be notified by their Program Official regarding the review outcome. Awards will be determined on the basis of scientific merit, program relevance, potential to build a translational research project, and availability of funds.  All funding decisions are final and not subject to appeal.

Budget Information

Applicants may request up to $100,000 in direct costs (exclusive of Facilities and Administrative (F&A) costs requested by consortium participants) for each year of the administrative supplements under this program. F&A costs will be paid at the full, negotiated rate.
 
Depending on the merit of the requests received and the availability of funds, the NIA may award up to $3.0 million per year in supplemental funding in connection with this funding opportunity announcement in FY09.  Approximately 20 supplement awards are anticipated.

Inquiries

Applicants are strongly encouraged to discuss their plans for responding to this Notice by phone or e-mail.

Scientific inquiries should be directed to the NIA Program Official who oversees the parent grant associated with the administrative supplement request. Additional questions regarding appropriateness of the project for this supplemental award may be addressed to the contacts listed below.

The earliest anticipated award date for this program will be February 1, 2009. However, the Award date for supplemental funding will be matched with the date of the next funding period of the parent grant.

Direct inquiries concerning programmatic and review matters to:

Chhanda Dutta, Ph.D.
Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307
Bethesda, MD 20892
Telephone (301) 435-3048
FAX: (301) 402-1784
Email: duttac@nia.nih.gov

Rebecca Fuldner, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C2231
Bethesda, MD 20892
Telephone: (301) 496-6402
FAX (301) 402-0010
Email: Fuldnerr@nia.nih.gov

Suzana Petanceska, PhD
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350
Bethesda, MD 20892
Telephone (301) 496-9350
FAX: (301) 496-1494
Email: petanceskas@nia.nih.gov

Georgeanne E. Patmios
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533
Bethesda, MD 20892
Telephone: (301) 496-3138
Fax: (301) 402-0051
Email: PatmiosG@NIA.NIH.GOV

Direct inquires regarding administrative and fiscal matters to:

Linda Whipp
Grants Management Officer
Grants and Contracts Management Office
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892
Telephone: (301) 402-7731
FAX: 301-402-3672
Email: whippl@nia.nih.gov


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